MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S3-4 13M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421538
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Injury (2348)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because a horsefly bit the patient on a replaced knee.Dr decided to replace the poly device and clean the knee (pulse lavage & antibiotics).
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, it has been communicated that clinical/medical documents will not be forth coming.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.Without the actual product involved our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The clinical/medical team concluded, it has been communicated that clinical/medical documents will not be forth coming.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.Without the actual product involved our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: GII CR DEEP FLEX ISRT S3-4 13M
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8028284
• Report Number: 1020279-2018-02305
• Device Sequence Number: 203075
• Product Code: JWH
• UDI-Device Identifier: 03596010512468
• UDI-Public: 03596010512468
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K041825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2015
• Device Catalogue Number: 71421538
• Device Lot Number: 05CM21610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/12/2018; 10/12/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 02/08/2019; 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention